Get yourdegree in Cognigenology.

If you’re anything like us, you can’t get enough of this pharmacometrics stuff. That’s why we’ve designed a series of training workshops to help you stay on top of the latest and greatest industry trends. Our discussions are hands-on, tailored to your organization, and, of course, incredibly insightful.

Have you been wondering how to quickly get up to speed with the use of NONMEM and the implementation of modeling and simulation in your development program? Well, here’s your chance to find out. Whether you’ve never used a modeling tool like NONMEM before and need to start from the basics or you’ve been trying to pick it up on your own and need to fill in some of the gaps in your understanding, this is the course for you. This workshop is structured to teach both the theoretical and practical aspects of the population approach using NONMEM, and is versatile so that participants with diverse backgrounds and areas of expertise may benefit. You’ll be presented numerous examples of population PK studies in drug development to illustrate best practices and hear lots of anecdotes about learning valuable lessons the hard way. Using our KIWI modeling platform, you’ll learn how to write control streams, evaluate covariate effects, discriminate between models, and understand and interpret the NONMEM output. We guarantee you’ll walk away with a whole new appreciation for what modeling and simulation with NONMEM and KIWI is all about.

It’s no surprise that pharmacometric modeling and simulation (M&S) have been proposed as tools to improve decision-making at drug development, regulatory reviews, and commercialization milestones. And while there’s a growing demand for M&S activities from regulatory agencies, M&S is still viewed as a “nice to have” rather than an integral component for decision-making. The goal of this 2-day workshop is to train pharmacometricians to become key contributing members of drug development project teams. Course material is provided as a combination of lectures and team-based exercises, and provides instruction in identifying and communicating the value of M&S in meeting the project-specific needs of the development team.

You’re confident in the models you’ve developed, and can defend the scientific basis of those models — but no one seems to understand what you’re presenting. Cognigen can work with you to discuss what the clinical teams are really looking for. We can also explain the complexity of the models in terminology that the teams will not only understand, but can respond to. With this knowledge, your teams can change the design of future trials as well as integrate modeling and simulation into the grain of drug development.

The assembly of NONMEM datasets is a time-intensive, but important step to ensure the accuracy of the population PK analysis-ready dataset. Deviation from the process, or automation without examination, can often result in incorrect and aberrant data within the dataset. This may ultimately adversely affect the model-based drug development decisions made by the clinical development team. By completing this workshop, you’ll be able to understand the idiosyncrasies of population PK models in relation to their data structure, identify data errors and the potential downstream consequences, and build an analysis-ready dataset for population PK modeling.

Everybody has read the NONMEM manuals. Maybe you’ve even run some NONMEM models. Now participate in a workshop that shows the scientific process you need to build a model. You’ll also learn the crucial skill of interpretation when the results don’t follow exactly what is in the book and help manuals.

Tuesday, September 26, 2017

Harness the power of pharmacometrics.

Raise your hand if you wish there was a way to make drug development more efficient. Guess what? There is. It’s called model-based drug development, and it involves using quantitative analysis to better design protocols, determine dosage levels, and figure out other neat stuff that lead to successful regulatory filings. Once you see how incredible (and cost-effective) pharmacometrics can be, you’ll be hooked.